NCT02056626

Brief Summary

The proposed research is designed to determine if the application of classical conditioning operations could influence the clinical effects of a regimen of antihypertensive drug therapy. It will be determined if, capitalizing on conditioned pharmacotherapeutic effects, patients can be effectively treated with smaller cumulative amounts of drug.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 13, 2019

Completed
Last Updated

July 9, 2019

Status Verified

June 1, 2019

Enrollment Period

7.8 years

First QC Date

February 4, 2014

Results QC Date

May 23, 2019

Last Update Submit

June 26, 2019

Conditions

Hypertension

Keywords

hypertension

Outcome Measures

Primary Outcomes (3)

  • Mean Systolic Blood Pressure

    day 0

  • Mean Systolic Blood Pressure

    day 14

  • Mean Systolic Blood Pressure

    day 30

Study Arms (4)

arm 2

ACTIVE COMPARATOR

partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)

Drug: carvedilol

arm 3

ACTIVE COMPARATOR

controlled dosing schedule 6.25 mg twice daily (15 days)

Drug: carvedilol

arm 4

ACTIVE COMPARATOR

controlled dosing schedule 6.25 mg twice daily, every other day (15 days)

Drug: carvedilol

arm 1

ACTIVE COMPARATOR

standard therapy, 25 mg twice daily (15 days)

Drug: carvedilol

Interventions

carvedilolDRUG
arm 1arm 2arm 3arm 4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systolic blood pressure between 140-160 mmHG
  • between 18-80 years old

You may not qualify if:

  • abnormal renal function
  • currently pregnant, or trying to become pregnant
  • being treated with a beta-blocker
  • use of illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • WOLF S. Effects of suggestion and conditioning on the action of chemical agents in human subjects; the pharmacology of placebos. J Clin Invest. 1950 Jan;29(1):100-9. doi: 10.1172/JCI102225. No abstract available.

    PMID: 15399519BACKGROUND

  • LASAGNA L, MOSTELLER F, VON FELSINGER JM, BEECHER HK. A study of the placebo response. Am J Med. 1954 Jun;16(6):770-9. doi: 10.1016/0002-9343(54)90441-6. No abstract available.

    PMID: 13158365BACKGROUND

  • KNOWLES JB. CONDITIONING AND THE PLACEBO EFFECT: THE EFFECTS OF DECAFFEINATED COFFEE ON SIMPLE REACTION TIME IN HABITUAL COFFEE DRINKERS. Behav Res Ther. 1963 Aug;1:151-7. doi: 10.1016/0005-7967(63)90018-4. No abstract available.

    PMID: 14153340BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Limitations and Caveats

This study was under enrolled and therefore not powered to answer the hypothesis.

Results Point of Contact

Title
John Bisognano
Organization
University of Rochester
john_bisognano @ urmc.rochester.edu
585-341-7800

Study Officials

  • John D. Bisognano, M.D., Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 6, 2014

Study Start

March 1, 2011

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

July 9, 2019

Results First Posted

June 13, 2019

Record last verified: 2019-06

Locations

US(1)